Horiba Instruments Inc: Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following certain alarms appear on the system.

Agency Publication Date: April 22, 2016

Affected Products

Product: ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.

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Product: Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.

All lot/serial #s

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73349

Status: Resolved

Manufacturer: Horiba Instruments Inc

Manufactured In: United States

Units Affected: 2 products (201)

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Sources: FDA iRES · Raw API Response

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Affected Products

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